CENTRAL WASHINGTON UNIVERSITY
HUMAN SUBJECTS REVIEW COUNCIL (HSRC) APPLICATION
HSRC Office
Black Hall, Room 225-17
400 East University Way
Mail Stop 7401
Ellensburg WA 98926-7401
(509) 963-3115
Fax: (509) 963-1064
BOX FOR COUNCIL USE ONLY

MASTER

REVIEWER
HSRC APPLICATION NUMBER:
_____________________________________________________
______________________
HUMAN SUBJECTS REVIEW COUNCIL SIGNATURE
DATE

APPROVE

DISAPPROVE
Notes:
Period of approval is no more than one year. Approved from _____________________________ through __________________________.
THIS APPROVAL IS VALID ONLY AS LONG AS APPROVED PROCEDURES ARE FOLLOWED
Instructions:


DO NOT LEAVE ANY BLANKS; if the item is not applicable to your study, please mark “N/A” in the designated space.
Send this completed application form with inked signatures and all attachments (e.g., consent forms, questionnaires, instruments, data
collection forms, debriefing statements, recruitment advertisements) to the HSRC Office.

Send an electronic Microsoft Word copy of application and all attachments to hsrc@cwu.edu.

If this is funded research, please provide one copy of the complete grant proposal with this application.

If this is thesis research, please provide one copy of the introduction and methods sections with this application.
For assistance in completing this form, refer to the HSRC Application Help Manual or call the HSRC Office.
The contents of this application and attachments will be kept confidential within the limits of state and federal law.
Check here if your project falls into one or more of the Minimal Risk (or “Expedited”) categories of research (see Expedited
Categories for listing of categories). If this project is determined to require full council review, the principal investigator will be
contacted and eight additional copies will be requested.
I. PRINCIPAL INVESTIGATOR. (Provide all the information requested. All correspondence from the HSRC will be directed to this
person.)
Name:
Title:
Department/Division:
Mail Stop:
Address to mail correspondence to:
Contact Phone Number:
Fax:
Contact E-mail:
II. TITLE OF RESEARCH PROJECT:
Anticipated start date:
Anticipated completion date:
III. SIGNATURES. The undersigned acknowledges that: (1) this application represents an accurate and complete description of the
proposed research; (2) the research will be conducted in compliance with and only after approval has been received from the Human
Subjects Review Council (HSRC). The principal investigator understands that he or she is responsible for immediately reporting any
unanticipated problems to the HSRC, for requesting prior HSRC approval for modifications in study documents or procedures, and for
requesting continuing review and approval of the study before its approval expires.
A. Investigator:
25Feb2013
Typed Name:
Professional Title:
Investigator Signature
Date
Page 1 of 10
III. SIGNATURES (continued):
B.
Faculty Sponsor (if principal investigator is a student):
Typed Name
Typed Title
Department
Sponsor’s Phone Number
Mail Stop
Faculty Sponsor’s Signature
C.
Date
The Chair, Dean, or Director signing below acknowledges that this proposed activity has received local review and approval of
scientific merit. Note: All investigators must have the signature of their chair, dean, or director.
Typed Name
Typed Title
Department/College/Division
Mail Stop
Chair/Dean/Director Signature
Date
Campus Phone
IV. CO-INVESTIGATORS (Provide all the information requested for each co-investigator. Co-investigators are those individuals
you expect to have contact with prospective subjects and/or the research data. (Thesis Council members are not co-investigators
unless they are actively involved in the procedures.) Copy and paste additional lines if necessary.
Name:
Title:
Department/Division:
Local Telephone Number:
E-mail:
Campus Mail Stop or Local Address:
Name:
Title:
Department/Division:
Local Telephone Number:
E-mail:
Campus Mail Stop or Local Address:
V.
FUNDING SOURCES. List each proposed and funded non-CWU grant or contract relevant to this application.
Note: NSF or NIH funded research may require additional RCR training. Contact Graduate Studies and Research for more details.
IF NONE, please check here.
A. Type of Proposal:
Research
Contract
Grant
Subcontract
B. Name of Principal Investigator on Grant or Contract:
C. Name of Funding Agency:
D. Title of Proposal Submitted to Funding Agency:
E. Funding Dates
From
through
F. Has this grant proposal been submitted to the CWU Office of Grants and Contracts for review?
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Page 2 of 10
Yes
VI.
No
If No, please attach a letter of explanation.
SUMMARY OF RESEARCH ACTIVITY. INSTRUCTIONS: Answer in the spaces provided. (Do not merely refer to an
accompanying grant or thesis proposal; rather, answer each question on this human subjects application form.) The space for each
answer will expand as you type. If necessary, attach additional information on separate sheets at the end of this document, labeling
each addition with the corresponding item number and/or letter.
A.
PURPOSE OF THIS RESEARCH. Provide a brief description of the purpose(s) of the proposed research, including relevant
background information (i.e., previous research findings) and the specific research questions or hypotheses this study is designed
to address. Note that the Council includes members with both scientific and non-scientific background. For a faster and more
thorough review, we ask that you use lay language throughout the application.
B.
RESEARCH PROCEDURES INVOLVED:
1.
Using lay language, provide a complete description of:

The study design

Sequence and timing of all steps of the study from recruitment to data analysis in enough detail that reviewers can
flowchart the entire process. Be sure to include such things as names of instruments to be used, anticipated time
required to complete each procedure, approximate total time subjects might anticipate being involved, etc.

List and attach copies of all data collection instruments (include documentation as detailed in Guidelines on use of
non-original instruments.)

If your study involves multiple phases (e.g., pilot testing, screening, delivery of intervention), please provide requested
information for each phase of the study.
2.
Would subjects undergo these or similar procedures (psychological, educational, etc.) if they were not taking part in this
research?
Yes
No
Please explain:
C.
DECEPTION.
1. Is the use of deception or withholding of complete information from subjects required for this research activity?
Yes
If Yes, please explain why this is necessary.
No If No, skip to Section D.
2. Attach a copy of the script or handout that will be used in debriefing subjects upon completion of their participation. Explain
when, how, and by whom subjects will be debriefed.
D.
SUBJECTS: (Please refer to the following guidance documents before completing this section: Non-discriminatory Subject
Recruitment and Subject Recruitment and Extra Credit)
1.
Will you involve minors (those under 18) as subjects in your study?
Yes
2.
25Feb2013
If Yes, please read assent/permission and follow instructions.
How many subjects will you need to complete this study?
Number:
No
Age range:
Page 3 of 10
3.
Explain how you will achieve equitable subject representation in the following categories. (If this is not applicable to your
study, justify your exclusions.)
a.
Age (minors, elderly):
b.
Gender (male, female):
c.
Ethnic and racial minority populations:
4.
What characteristics must subjects have to be in this study? (Answer for each subject group, if different.)
5.
What characteristics would exclude subjects who are otherwise eligible for your study? (Answer for each subject group, if
different.)
6.
How will you identify potential subjects? Describe the subject recruitment strategies you will use for each group of
subjects. (Attach all copies of advertisements, SONA study description, flyers, contact letters, telephone contact protocols,
web site information you will use for recruiting study participants.)
7.
Explain who will approach potential subjects to take part in the study and how this will be done to protect subjects’ privacy.
(Attach original letters of cooperation from those agencies, institutions, or others that will be involved in subject
recruitment.)
8.
Explain what steps you will take during the recruitment process to minimize potential coercion or undue influence.
9. Briefly detail any previous experience or background you may have had with your target population.
10. Will you give subjects gifts, payments, services without charge, or will extra course credit be made available?
Yes
If Yes, please explain.
No
11. Will any of the subjects or their third-party payers (e.g., health insurance company) be charged for any of your study
procedures?
Yes
If Yes, please explain
No
No cost to clients
12. Where will your study procedures be carried out? (Attach copies of IRB approvals or letters of cooperation, on letterhead,
from non-CWU sites.)
E.
25Feb2013
RISKS AND BENEFITS
Page 4 of 10
1a. Describe the nature and degree of risk of possible injury, stress, discomfort, disgrace, invasion of privacy, and other side
effects associated with each of your study procedures. Describe these risks in detail in this portion of the HSRC
application; do not simply refer to your consent form.
1b. Explain whether the procedures themselves could have an adverse effect on subjects, e.g., by focusing on negative feelings
or leading subjects to see themselves in a negative light. If so, describe the steps you will take to minimize these risks.
1c. Explain whether disclosure of the data could place the subjects, or groups to which they belong, at risk of criminal or civil
prosecution. If so, describe the steps you will take to minimize these risks.
1d. Explain whether disclosure of the data could place the subjects, or groups to which they belong, at risk of emotional
discomfort, embarrassment or humiliation. If so, describe the steps you will take to minimize these risks.
1e. Explain whether disclosure of the data could place the subjects, or groups to which they belong, at risk of losing their jobs,
insurance, personal relationships, eligibility for benefit or other programs, or otherwise harm their rights and welfare. If so,
describe the steps you will take to minimize these risks.
2.
Is there any possibility that subjects might suffer physical injuries as a result of your study?
Yes
No
If Yes, state what those injuries may be and check the appropriate box below indicating who will be financially
responsible for the treatment of these injuries.
Subject or subject’s insurer
Study sponsor (if funded research)
CWU (attach letter of authorization)
Other
If other, please specify:
3.
Is it possible that you will discover a subject’s previously unknown condition (e.g., disease, suicidal ideation, genetic
predisposition) as a result of your study procedures?
Yes
If Yes, please explain how you will handle these situations.
4. Who will handle unanticipated
problems?
Referral agencies (Attach a letter from
the agency stating they are aware of
Other
your study and are willing to accept
referrals.)
Please name the person handling unanticipated problems and describe their training and experience.
5.
Investigator(s)
No
Faculty
sponsor
Are your research facilities and equipment adequate to handle possible unexpected events?
Yes
No
Please explain your answer.
25Feb2013
Page 5 of 10
F.
6.
Do you anticipate that individual subjects in each subject group can reliably expect a direct benefit from study procedures?
(Please note that receiving financial payment or extra course credit is not considered a benefit of study participation.)
No
Yes If Yes, please describe the direct benefits.
7.
Describe the anticipated benefits of this research for society.
8.
Explain how the anticipated benefits of this research project outweigh the anticipated risks associated with your study
procedures.
9.
Will subjects be able to receive the results of your study?
Yes If Yes, please explain how this will happen.
If No, explain why.
CONFIDENTIALITY OF RESEARCH DATA
1.
Will you collect and use any direct individual identifiers (e.g., subjects’ names, student IDs, video or audio-recordings,
addresses, telephone numbers, IP addresses)?
Yes If Yes, please explain what identifiers will be
collected and why this is necessary. Also, describe
any coding system you will use to protect against
disclosure.
2.
25Feb2013
No
No
Data will be collected via Internet
Answer 2b taking into account
Internet Information Page
instructions
Will you retain subjects’ direct identifiers or a link between identifiers and study code numbers after the data collection is
complete?
Yes If Yes, answer a-c below.
No If No, answer only b below.
a.
Explain why this is necessary.
b.
Describe how you will protect study data against disclosure to the public or to other researchers or non-researchers
(e.g., coded master list stored separate from data, locked cabinet or office, restricted computer, etc.).
c.
Provide the estimated month/year you plan to de-link the study data from direct subject identifiers. If there is no plan
to do so, explain why.
3.
Explain who—other than members of the research team—will have access to your data (e.g., study sponsors (if funded
research), faculty sponsor, government agencies, Internet Survey sites like SurveyMonkey). In each case, specify whether
they will have access to study data with identifiers or only to coded data with no access to the identifying study code.
4.
Do you anticipate any circumstances under which you might be obliged or compelled to disclose data that could be linked
with an individual or group?
Yes If Yes, explain these circumstances and confirm that you have included
No
information about these exceptions to confidentiality in the consent process.
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5.
Will you place a copy of the consent form or other study information in the subject’s medical, counseling, educational, or
other personal record?
Yes If Yes, please explain where you intend to store a copy of the consent form;
No
confirm that you have included information about the storage in the consent process.
6.
Do you anticipate using the raw data from this study for other studies in the future?
Yes If Yes, please explain, including whether data will be retained in identifiable
form, and confirm that you have included information about the future use of data in the
consent process.
No
G. ADDITIONAL INFORMATION
1.
Will you need access to subjects’ medical, academic, or other personal records for screening or data collection purposes?
Yes If Yes, please specify the types of records, what information you will take from
No
the records, and how you intend to use this information.
2.
Will you make audio-visual or tape recordings or photographs of subjects?
Yes
If Yes, explain (a) what type of recordings you will make, (b) how long you
will keep them, (c) what procedures you intend to use for storing them, and (d) who, if
anyone, other than members of the research team, will be able to see or hear them.
No
3.
Will your study involve use of equipment involving energy input to subjects (e.g., ultrasound, muscle stimulation unit,
etc.)?
Yes If Yes, attach documentation specifying that all equipment will be regularly tested
No
for safety and state who will test it.
4.
Does any member of the research team have a financial interest in the research or its products or in the study sponsor (i.e.,
funding source)?
Yes If Yes, please include documentation that conflicts of interest have been reviewed
No
by Research and Sponsored Programs.
5.
Does any member of the research team have a potential non-financial conflict of interest with potential study participants
(e.g., teacher of participants or relative of participant )?
Yes
If Yes, please describe how these potential conflicts of interest will be
No
managed in order to minimize risks to subjects.
H. INFORMED CONSENT
Informed consent is an ongoing process, not a piece of paper or a discrete moment in time. Informed consent assures that
prospective human subjects will understand the nature of the research and can knowledgeably and voluntarily decide whether
to participate. If some or all subjects are minors, see guidance on completing this section. If using the Internet for data
collection, see guidance on Internet Research Issues.
1.
Please explain how you will make sure that your subjects are legally and mentally competent to provide informed consent to
be in your study.
2a. Please explain the process for informing subjects and how you will assess their understanding about being in the study
before you accept their consent.
25Feb2013
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2b. List each of the consenting documents along with the Flesch-Kincaid Grade Level for each.
3.
Will all subjects in your study understand and read English?
Yes
No
If No, please list all documents that will need to be translated (e.g., consent form, recruitment materials, surveys, debriefing,
etc.). (At time of application, include the English versions of documents; HSRC will contact you for translated documents
before final approval.)
If subjects do not read, explain how you will obtain consent.
4a. Consent Materials and Procedures. An informed consent or permission process includes all the elements listed below.
Carefully review your consent document(s) for these elements. If there is a compelling reason, you may request that use of
a consent document be waived.
Request entire consent document be waived
OR
Check all elements below that are NOT included in your consent document:
A statement that the study involves research
An explanation of the purposes of the research
The expected duration of the subject’s participation
A description of the procedures to be followed
A description of any reasonably foreseeable risks or discomforts to the subject
A description of any benefits to the subject or to others which may reasonably be expected from the research
A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
For research involving more than minimal risk, an explanation as to whether any compensation and/or medical treatments
are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
An explanation of whom to contact for answers to pertinent questions about
the research,
the research subject’s rights, and
whom to contact in the event of a research-related injury to the subject (if reasonably foreseeable)
A statement to the effect that “participation is voluntary, your refusal to participate or to continue participation will involve
no penalty or loss of benefits to which you are otherwise entitled, and you may discontinue participation at any time.”
Under certain circumstances, additional elements may be required per 45 CFR 46.116
4b. If you have left out of your consent document any or all of the elements listed in 4a above, please answer each of the
following. All four regulatory requirements [per 45 CFR 46.116(d)] must be met in order for any element(s) to be waived.
4c.
25Feb2013
(1.) The research in its entirety involves no more than minimal risk.
Yes
No
(2.) The waiver of informed consent will not adversely affect the rights and
welfare of the subjects.
Yes
No
(3.) It is not practicable to conduct the research without the waiver/alteration.
Yes
No
(4.) Whenever appropriate, subjects will be provided with additional
pertinent information after their participation (e.g., debriefing).
Yes
Not
appropriate
Will you ask subjects to sign consent, assent, or permission documents?
Yes
No
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If Yes, attach a copy of each consent, assent and permission form you will use for each subject group in this study.
Note: Sample consent, parent permission and assent forms, as well as guidelines for writing consent
forms, are available on the HSRC website forms page (http://www.cwu.edu/hsrc/forms).
If No, select from below the reason(s) for requesting a waiver of signed written consent. Attach a copy of the consent form
(without signature line), information sheet, script, or verbal process you will use for each subject group in this study.
The research presents no more than minimal risk of harm to subjects and involves no procedures for which written
consent is normally required outside of the research context.
The only record linking the subject and the research would be the consent document, and the principal risk would be
potential harm resulting from a breach of confidentiality.
Waiver of the entire consent document is requested in 4a above.
25Feb2013
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HSRC APPLICATION CHECKLIST
Before submitting your human subjects application to the HSRC, please review it carefully. Complete the following checklist to
ensure that you have included all necessary attachments to the HSRC application. To be complete, you must provide the original
application with signatures and all attachments. Also, you must send an electronic version of the entire application with attachments
to hsrc@cwu.edu
Required RCR Training has been completed by all investigators and co-investigators. Study will not be
approved until entire research team completes RCR Training.
Attach certificate if training was not completed through CWU HSRC tutorial or in-class presentation.
Yes
No
Yes
No
NA
For funded research projects, provide one complete copy of the funding/grant proposal
Yes
No
NA
For thesis research, provide one copy of the introduction and methods sections
Yes
No
NA
For all projects, attach copies of written consent, permission and assent forms
Yes
No
NA
Yes
No
NA
Yes
No
Yes
No
NA
For Internet-based data collection, attach Internet Survey Security Form or other security information as
appropriate.
Yes
No
NA
If grant proposal has not been reviewed and cleared by CWU Office of Grants and Contracts, attach a brief
letter of explanation
Yes
No
NA
For projects involving multiple phases or complex designs, attach flow chart(s) describing the sequence of
study procedures
Yes
No
NA
For projects involving deception, provide debriefing script.
Yes
No
NA
If equitable selection of subjects will not be used, there is written justification for your exclusions.
Yes
No
NA
If other agencies or institutions will be involved in recruitment or data collection activities, attach originals
of letters of cooperation from these organizations.
Yes
No
NA
If study procedures will be carried out at other institutions, attach copies of IRB approvals or the original
letters of cooperation from those institutions.
Yes
No
NA
If equipment involving energy input to subjects (e.g., ultrasound, muscle stimulation unit, etc.) will be
used, attach documentation specifying procedures for regular testing of equipment safety.
Yes
No
NA
If any member(s) of the research team has a financial interest in the research, its products, or the funding
source, attach documentation that these financial conflicts of interest have been reviewed by the Office of
Grants and Contracts.
Yes
No
For all projects, attach copies of research materials (e.g., questionnaires, data forms). See Guidelines for
Use of Copyrighted, Licensed or Other Non-original Instruments if instruments are not authored by the
investigator.
For all projects, attach copies of recruitment materials (e.g., scripts, advertisements, SONA study
description)
All required inked signatures from Section III have been obtained
Send an electronic version of the entire application with attachments to hsrc@cwu.edu
HSRC is providing a list of names of principal investigators, research titles, and approval dates via the HSRC website in the belief that the
university community benefits from the availability of this information.
I give permission to post my name, study title, and approval date on a list which is linked to the HSRC website.
I prefer not to have my name, study title, and approval date listed on the HSRC website.
25Feb2013
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